Phase I Irinotecan, 5-Fluorouracil and Leucovorin Combination - Full Text View

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00507091

Purpose

A Phase I open label study to asses the safety and tolerability of ZD6474 in combination with Irinotecan, 5-Fluorouracil and Leucovorin (FOLFIRI) as first or second line therapy in patients with metastatic colorectal adenocarcinoma.

Condition	Intervention	Phase
Metastatic Colorectal Adenocarcinoma	Drug: ZD6474 (vandetanib) Drug: Irinotecan Drug: 5-Fluorouracil Drug: Leucovorin	Phase I

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase I Open Label Study to Asses the Safety and Tolerability of ZD6474 (Vandetanib)in Combination With Irinotecan, 5-Fluorouracil and Leucovorin (FOLFIRI) as First or Second Line Therapy in Patients With Metastatic Colorectal Adenocarcinoma.

Resource links provided by NLM:

Drug Information available for: Fluorouracil Leucovorin Citrovorum factor Irinotecan U 101440E Irinotecan hydrochloride Vandetanib Leucovorin Calcium Folinic acid calcium salt pentahydrate

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Establish the safety & efficacy of ZD6474 w/5-fluorouracil,leucovorin & oxaliplatin to patients with advanced colorectal adenocarcinoma, by assessment of AEs, vital signs, clinical chemistry, hematology, urinalysis, ECG and physical examinations [ Time Frame: assessed at each visit ] [ Designated as safety issue: No ]

Enrollment:	22
Study Start Date:	August 2005
Study Completion Date:	June 2008
Primary Completion Date:	May 2006 (Final data collection date for primary outcome measure)

Intervention Details:

once daily oral tablet

Other Name: ZACTIMA™

intravenous infusion

Other Name: Camptosar®

intravenous infusion

Other Name: 5-FU

intravenous infusion

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Confirmed metastatic colorectal adenocarcinoma
Not amenable to surgery or radiation therapy
For first or second line chemotherapy

Exclusion Criteria:

Brain metastases or spinal compression
Last prior chemotherapy discontinued within 4 weeks before start
Last dose radiotherapy within 4 weeks of start

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00507091

Locations

Belgium
Research Site
Gent, Belgium
United Kingdom
Research Site
Belfast, United Kingdom
Research Site
Manchester, United Kingdom

Sponsors and Collaborators

AstraZeneca

Investigators

Principal Investigator:	Mark Saunders, MD	AstraZeneca
Study Director:	Peter Langmuir	AstraZeneca

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00507091 History of Changes
Other Study ID Numbers:	D4200C00038
Study First Received:	July 10, 2007
Last Updated:	April 3, 2009
Health Authority:	United Kingdom: National Health Service; Belgium: Ministry of Social Affairs, Public Health and the Environment

Keywords provided by AstraZeneca:

ZD6474
Irinotecan
5-Fluorouracil
Leucovorin
colorectal

Additional relevant MeSH terms:

Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Fluorouracil
Irinotecan
Leucovorin
Levoleucovorin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses

Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Antidotes
Protective Agents
Antineoplastic Agents, Phytogenic
Radiation-Sensitizing Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on February 12, 2012